NeuroSense Therapeutics has reported that the Phase IIb PARADIGM clinical trial of its drug candidate, PrimeC, in amyotrophic lateral sclerosis (ALS) patients met the primary and secondary endpoints.
The double-blind, randomised, multinational, placebo-controlled trial analysed PrimeC in ALS subjects in Israel, Canada, and Italy for six months.
These subjects were randomised into a 2:1 ratio to receive the drug or a placebo.
Data showed that the trial met the primary safety and tolerability endpoints, and the drug’s safety and tolerability profile was similar to that of the placebo.
The subjects in the PrimeC arm reported a decline in disease progression, including sustained daily function over six months.
The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and Slow Vital Capacity (SVC), which evaluate respiratory function, were the secondary clinical efficacy endpoints of the trial.
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A 29% difference, favouring the treatment with PrimeC in the ALSFRS-R outcome, and a 13% difference in SVC was reported.
The extended-release oral formulation comprises fixed doses of two Food and Drug Administration-approved drugs, ciprofloxacin and celecoxib.
NeuroSense CEO Alon Ben Noon said: “The release of this portion of the top-line results of the PARADIGM trial marks an exciting milestone for NeuroSense as we take another step toward helping people suffering from this dire disease.
“We look forward to meeting with the FDA to determine the best path forward and to advancing discussions with strategic partners who share our vision for PrimeC to benefit people living with ALS.”
The company plans to report data from a strategic partnership with Biogen in January next year. The alliance is assessing PrimeC’s impact on neurofilament levels in ALS subjects who are part of the PARADIGM trial.
On obtaining the data, Biogen holds the right of first refusal for jointly developing/commercialising PrimeC for ALS for a stipulated period.